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Doing Business In MEXICO

To market health and beauty products in MEXICO, you must first register with the appropriate local agency: COFEPRIS, (Mexico Federal Commission for the Protection against Sanitary Risk).

The COFEPRIS registration must be obtained before any commercial application for the following types of products:

  • Cosmetics
  • Medical Devices
  • Sanitary Products
  • Pharmaceuticals and drugs
  • Food & Supplements

This administratively complex process involves a high level of risk. Our services are intended to reduce this risk (commercial, legal, and technical) by taking these time-consuming steps for you.

Good To Know

Beyond navigating complex administrative issues, our work deals with a number of practices unique to Mexican business culture:

  • Registration must be requested through a local and reputable Mexican company that will own these records EXCLUSIVELY for five years.
  • The company must be in good standing and fully authorized by COFEPRIS.
  • This procedure is different and more complex than FDA.
  • The application process takes 6 to 12 months at least, before your registration goes into effect.
  • The registration is always held by the company that filed the application.
Three Options Only

There are basically three ways to access the Mexican market.

  • #1
    Having your own local branch (creation, merger/JV or acquisition): this approach involves the registration of your subsidiary and products in order to bring your products to Mexico. This option is usually slow and costly (medical staff hiring, etc.) and best justified for proven markets and businesses with high investment capacity and international infrastructure.
  • #2
    Using a local distributor: you will need to find and negotiate with a local distributor knowing that it usually carries several competing brands and often focus on one region or state. Statistically, this option most of the time, results in failure within 24 months and becomes very costly.
  • #3
    Joining forces with a trusted third party recognized by COFEPRIS, Mandala International (master distributor), get you up and competing faster and at much less cost with lower risk.

Having your own local subsidiary

1
Cost
High
  • Property Investment(s)
  • Employing a doctor and / or pharmacist.
  • Business trips.
Implementation
12 to 18 months
  • Creating a business structure.
  • Registering your affiliate.
  • Registering your products.
Risk Level
Medium
  • Legal risks.
  • Salery and wage risks.
  • Commercial failure risks.
  • Automonomy,and independence.

Outsourcing to one of your local distributors

2
Moderate
  • Negotiating and ratifying a contract.
  • Often with a reference product and high commission.
  • Annual negociation. Registration taxes can be paid by the local company
10 to 12 months
  • Language and translation barriers in carrying out your requests.
  • Lack of responsiveness and transparency from the distributor.
  • Difficulties to train the distributor to your product.
High
  • Legal risks (Mexican contracts law).
  • Commercial risks (Competing products).
  • Risks associated with the ownership of your registration (exclusive rights).
  • Obligation to rely on Distributor.

Working with trusted third party specialized in regulatory issues (Master Distributor)

3
Low
  • Presentation of a clear and accurate estimate.
  • Fixed amount per product (with discounts for multiple products).
8 to 10 months
  • Expedited process based on access and established relationship with COFEPRIS
  • Your own dedicated bilingual contact.
  • Documentation and case management should be included.
  • Transparency and full autonomy.
Low
  • No salary, administrative or overhead costs.
  • Operated by a solid and trusted third party who can provide local assistance whenever you need it.
  • No exclusivity agreements.
  • Choice of commercial partners (local distributors) and control of sales volume.
Our solution offre ANVISA Bresil

We aim to:

  • - Become your regulatory partner
  • - Be your administrative and commercial intermediary
  • - Register your products and/or business using a local law firm
  • - Keep and host your records and licenses
  • - Import and distribute your products (medical devices, cosmetics, pharmaceutical, dental, sanitary products, and drugs.)
This solution has many advantages:
  • - You remain independent and autonomous
  • - You choose all local distributors freely
  • - You can determine for yourself when and how you want to sell your products
  • - We take care of your regulatory and administrative requirements…
  • - We bring you the guarantee of a European organization with a solid team of professionals, that is respectful of legal and ethical principles
MANDALA Brasil also offers two additional benefits, with our customized service:
  • Studying and Finding the right Distributors for you

    Do you want to better understand the market before you decide to invest there?

  • MANDALA Brasil delivers a specific six months assignment, including:

  • - A study of the market and specific business opportunities .
  • - Research and a selection of the best regional distributors (solid, reliable and authorized by ANVISA), specializing in your products.
  • - A study of financial and regulatory issues.

  • Our service includes a week in Brazil conducting face-to-face meetings with qualified local distributors and / or potential partners.

Assessment and Quality Management
  • Do you worry that your business must obtain a Certificate of Good Manufacturing Practice and approval by ANVISA?

    Because registration of your local subsidiary or distributor is required every two years, your company must maintain Certificate of Good Manufacturing Practice. An extremely detailed audit of the tools and methods of production you employ is conducted on your premises by ANVISA.

    MANDALA Brazil will perform a preliminary audit, complete with a technical report detailing our recommendations to guarantee compliance with all ANVISA requirements. (See Our Procedures page)

Procedure

While Mexico represents a growing market with a population of 110 million inhabitants and is the second largest medical device market in Latin America behind Brazil, it is also one of the most confusing, and time-consuming (administrative and protectionist) markets to navigate, one requiring considerable investment resources.

Our dedicated guidance is intended to help and let you access this country’s business culture making it easier for you to make realistic and cost beneficial decisions, while at the same time leaving you free to choose your distributors and buyers.

A proven approach,
safe and secure
»
Optional pre Study : Market and Distribution Survey2
  • 3 months survey
  • Meetings with future and potential partners, distributors, etc… for a week in Mexico
#1
First Meeting and Personalized Consultation.
  • Presentation of our sales teams and techniques.
  • Examination and Corroboration of your penetration strategy, the products, and the market.
#2
Authorization to Carry Out a Preliminary Analysis
  • Securing and Assessing the legal and economic framework.
  • Pricing based on the number of products concerned.
#3
Audit and Preliminary Findings
  • Determination of the product category (single, family, or system).
  • Definition of regulatory prerequisites (registration or notification).
  • Evaluation of classification within the definition of COFEPRIS, the National
  • Health Surveillance Agency of Mexico. 1
  • Identification of other required certifications.
#4
Services and Contract
  • Determination of fees for necessary registration or notification.
  • Assessment of ANVISA taxes.
  • A five-year economic business plan for hosting.
  • Examination of all legal and regulatory requirements.
#5
Procedure for registration or notification.
  • Writing and developing appropriate presentation documents.
  • Validating certifications.
  • Filing and following up with relevant agencies.
#6
Official Mexican Publication (COFEPRIS website)
  • Proofreading of the registration certificates.
  • Ensure the issuance of administrative documents.
  • Start selling your product.
#7
Monitoring and Securing Business Environment
  • Maintain records.
  • Alert you to changes in regulatory requirements and certifications.
  • Audit selected distributors to ensure legal compliance, COFEPRIS requirements,and financial health. 2
  • Issue and track Import Letters
Download our Cofepris brochure

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